MUCUS AND CHEST CONGESTION

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:07

Label at a glance#

ProductMUCUS AND CHEST CONGESTION
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over:   1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over:
  • 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health®

MUCUS & CHEST CONGESTION

GUAIFENESIN

EXTENDED-RELEASE TABLETS, 600 mg

Expectorant

EXTENDED-RELEASE

Relieves chest congestion

Thins & loosens mucus

Immediate & Extended Release

12 HOUR

Compare to the active ingredient in Mucinex®

20 TABLETS

Actual Size

cvshealth-mucus-&-chest-congestion-carton-image.jpg
cvshealth-mucus-&-chest-congestion-carton-image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-299-01MUCUS AND CHEST CONGESTION1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL12
51316-299-01MUCUS AND CHEST CONGESTION20 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL202

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-29951316-299-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078912-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23
A078912-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23bb7c543d1eb4…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS AND CHEST CONGESTIONGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf505e0bd-8881-4e51-a2fc-4e649bac3bff2026-01-14WarningsExact identifier
ndc (package): 51316-299-01
ndc (product): 51316-299
ndc11 (package): 51316029901
spl id: 823e09e1-2d32-4673-a443-142e5ea8edfb
spl set id: f505e0bd-8881-4e51-a2fc-4e649bac3bff

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.